Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting — ZENSHIN  

Prostatic Neoplasms Clinical Trial

Official title: Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients.

<Methods> Study design: multi-center, prospective cohort study

Data Source(s):

In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern

Sample Size Estimations:

The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).

Statistical Analysis:

This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT04425200
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Start date: July 29, 2020
• Completion date: December 18, 2020